Cleared Traditional

K810047 - AUTOPHOR 128

K810047 is the FDA 510(k) clearance for AUTOPHOR 128 by Gelman Sciences, Inc.. It is a Class 2 Chemistry device (product code JBD) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K810047 · Gelman Sciences, Inc. · Chemistry device
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Feb 1981
Decision
24d
Days
Class 2
Risk

K810047 is an FDA 510(k) clearance for the AUTOPHOR 128. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 5, 1981 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7440 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gelman Sciences, Inc. devices

Submission Details

510(k) Number K810047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1981
Decision Date February 05, 1981
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBD System, Analysis, Electrophoretic Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JBD System, Analysis, Electrophoretic Hemoglobin

All 19
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K810047.
LABILE REMOVING HEMOLYZING REAGENT
K830804 · Corning Medical & Scientific · May 1983
CELLULOSE ACETATE-CITRATE AGAR HEMOGLO
K813395 · Helena Laboratories · Dec 1981
HEMOGLOBIN ELECTROPHORESIS CONTROL
K810919 · Isolab, Inc. · Apr 1981
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
K802884 · Corning Medical & Scientific · Dec 1980
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
K802821 · Beckman Instruments, Inc. · Dec 1980
A,SA2 LYOPHILIZED HEMO CONTROL
K800853 · Helena Laboratories · Apr 1980